TRANDATE Injection is usually well tolerated. Most adverse effects have been mild and transient and, in controlled trials involving 92 patients, did not require labetalol HCl withdrawal. Symptomatic postural hypotension (incidence, 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving TRANDATE Injection. Moderate hypotension occurred in 1 of 100 patients while supine. Increased sweating was noted in 4 of 100 patients, and flushing occurred in 1 of 100 patients.

The following also were reported with TRANDATE Injection with the incidence per 100 patients as noted:

Cardiovascular System: Ventricular arrhythmia in 1.

Central and Peripheral Nervous Systems: Dizziness in 9, tingling of the scalp/skin in 7, hypoesthesia (numbness) and vertigo in 1 each.

Metabolic Disorders: Transient increases in blood urea nitrogen and serum creatinine levels occurred in 8 of 100 patients; these were associated with drops in blood pressure, generally in patients with prior renal insufficiency.

Psychiatric Disorders: Somnolence/yawning in 3.

Respiratory System: Wheezing in 1.

Skin: Pruritus in 1.

The incidence of adverse reactions depends upon the dose of labetalol HCl. The largest experience is with oral labetalol HCl (see TRANDATE® [labetalol hydrochloride] Tablets Product Information for details). Certain of the side effects increased with increasing oral dose, as shown in the following table that depicts the entire US therapeutic trials data base for adverse reactions that are clearly or possibly dose related.

Labetalol HCI

Daily Dose (mg)

200

300

400

600

800

900

1200

1600

2400

Number of patients

522

181

606

608

503

117

411

242

175

Dizziness (%)

2

3

3

3

5

1

9

13

16

Fatigue

2

1

4

4

5

3

7

6

10

Nausea

<1

0

1

2

4

0

7

11

19

Vomiting

0

0

<1

<1

<1

0

1

2

3

Dyspepsia

1

0

2

1

1

0

2

2

4

Paresthesia

2

0

2

2

1

1

2

5

5

Nasal stuffiness

1

1

2

2

2

2

4

5

6

Ejaculation failure

0

2

1

2

3

0

4

3

5

Impotence

1

1

1

1

2

4

3

4

3

Edema

1

0

1

1

1

0

1

2

2

In addition, a number of other less common adverse events have been reported:

The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with labetalol HCl during investigational use and extensive foreign marketing experience.

Clinical Laboratory Tests: Among patients dosed with TRANDATE Tablets, there have been reversible increases of serum transaminases in 4% of patients tested and, more rarely, reversible increases in blood urea.